Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MESH, LARGE GRID, PDLLA
KLS-Martin L.P.
52-306-12-04
In Commercial Distribution

  • 00888118000552 ()

  • 126 X 126 MM, T=0.6 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, SMALL GRID, PDLLA
KLS-Martin L.P.
52-303-81-04
In Commercial Distribution

  • 00888118000545 ()

  • 81 X 81 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, FOIL, PDLLA
KLS-Martin L.P.
52-303-52-04
In Commercial Distribution

  • 00888118000521 ()

  • 51 X 51 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, LARGE GRID, PDLLA
KLS-Martin L.P.
52-303-26-04
In Commercial Distribution

  • 00888118000484 ()

  • 29 X 29 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, SMALL GRID, PDLLA
KLS-Martin L.P.
52-303-25-04
In Commercial Distribution

  • 00888118000477 ()

  • 26 X 26 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, MEMBRANE, PDLLA
KLS-Martin L.P.
52-302-30-04
In Commercial Distribution

  • 00888118000460 ()

  • 50 X 20 MM, T=0.2 MM


  • Craniofacial fixation plate, bioabsorbable
PLATE, BADIE, PDLLA
KLS-Martin L.P.
52-042-20-04
In Commercial Distribution

  • 00888118000125 ()

  • 16 X 9 MM, T=0.3 MM


  • Craniofacial fixation plate, bioabsorbable
PLATE, BADIE, PDLLA
KLS-Martin L.P.
52-042-18-04
In Commercial Distribution

  • 00888118000101 ()

  • 10 X 5 MM, T=0.6 MM


  • Craniofacial fixation plate, bioabsorbable
MESH, SMALL GRID, PDLLA
KLS-Martin L.P.
01-310-13-04
Not in Commercial Distribution

  • 00888118000002 ()

  • 126 X 11 MM, T=2.0 MM


  • Craniofacial fixation plate, bioabsorbable
No Description
Shenzhen Urion Technology Co., Ltd
LXBPC-UA
In Commercial Distribution

  • 06953825904418 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
No Description
Shenzhen Urion Technology Co., Ltd
U80A
In Commercial Distribution

  • 06953825902223 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
PLASMABLADEX PS210-030S-LIGHT 3.0SL PINK
MEDTRONIC NAVIGATION, INC.
PS210-030S-LIGHT
In Commercial Distribution

  • 00763000279189 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS210-030S-LIGHT 3.0SL
MEDTRONIC NAVIGATION, INC.
PS210-030S-LIGHT
In Commercial Distribution

  • 00763000279165 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS210-030S-LIGHT 3.0SL
MEDTRONIC NAVIGATION, INC.
PS210-030S-LIGHT
In Commercial Distribution

  • 00763000279172 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS200-041S 4.0S GREEN
MEDTRONIC NAVIGATION, INC.
PS200-041S
In Commercial Distribution

  • 00763000279141 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
No Description
Tura Inc.
VGS014 GLD 60
In Commercial Distribution

  • 00764724865153 ()

  • Width: 60 Millimeter


  • Spectacle frame
No Description
Tura Inc.
VGS011 GLD 58
In Commercial Distribution

  • 00764724860622 ()

  • Width: 58 Millimeter
VGS011 GLD 58

  • Spectacle frame
No Description
Tura Inc.
VGS011 BLK 58
In Commercial Distribution

  • 00764724860615 ()

  • Width: 58 Millimeter
VGS011 BLK 58

  • Spectacle frame
No Description
Tura Inc.
VGS003 BLK 58
In Commercial Distribution

  • 00764724856083 ()

  • Width: 58 Millimeter


  • Spectacle frame
No Description
Tura Inc.
VGS002 CRY 55
In Commercial Distribution

  • 00764724856076 ()

  • Width: 55 Millimeter


  • Spectacle frame
No Description
Tura Inc.
VGS002 BLK 55
In Commercial Distribution

  • 00764724856069 ()

  • Width: 55 Millimeter


  • Spectacle frame
STENT SFR4-6-40-10 V03 SOLITIARE4
Micro Therapeutics, Inc.
SFR4-6-40-10
In Commercial Distribution

  • 00763000425739 ()


  • Thrombectomy wire-net
STENT SFR4-6-24-06 V03 SOLITIARE4
Micro Therapeutics, Inc.
SFR4-6-24-06
In Commercial Distribution

  • 00763000425715 ()


  • Thrombectomy wire-net
STENT SFR4-6-20-10 V03 SOLITIARE4
Micro Therapeutics, Inc.
SFR4-6-20-10
In Commercial Distribution

  • 00763000425692 ()


  • Thrombectomy wire-net
STENT SFR4-4-40-10 V03 SOLITIARE4
Micro Therapeutics, Inc.
SFR4-4-40-10
In Commercial Distribution

  • 00763000425678 ()


  • Thrombectomy wire-net
STENT SFR4-4-20-10 V03 SOLITIARE4
Micro Therapeutics, Inc.
SFR4-4-20-10
In Commercial Distribution

  • 00763000425654 ()


  • Thrombectomy wire-net
STENT SFR4-4-20-05 V03 SOLITIARE4
Micro Therapeutics, Inc.
SFR4-4-20-05
In Commercial Distribution

  • 00763000425630 ()


  • Thrombectomy wire-net
STENT SFR4-3-20-10 V01 3X20
Micro Therapeutics, Inc.
SFR4-3-20-10
In Commercial Distribution

  • 00763000367619 ()

  • Stent Diameter: 3.0 Millimeter
  • Stent Length: 20.0 Millimeter


  • Thrombectomy wire-net
INS 97800 INTERSTIM X SSMRI AMER
MEDTRONIC, INC.
97800
In Commercial Distribution

  • 00763000484668 ()


  • Implantable incontinence-control electrical stimulation system pulse generator
INS 97800 INTERSTIM X SSMRI GLOBAL EMAN
MEDTRONIC, INC.
97800
In Commercial Distribution

  • 00763000892067 ()


  • Implantable incontinence-control electrical stimulation system pulse generator
G3 X APAP
BMC Medical Co., Ltd.
G46002
In Commercial Distribution

  • 06948538363560 ()


  • Home CPAP unit
G3 X APAP
BMC Medical Co., Ltd.
G4600
In Commercial Distribution

  • 06948538363553 ()


  • Home CPAP unit
Enables trained physicians to obtain cross-sectional and spectroscopic images of internal structures of the head, body or extremities, in any orientation, representing the spatial distribution of protons or other nuclei with spin.
Philips Medical Systems Nederland B.V.
781356
In Commercial Distribution

  • 00884838090040 ()


  • Full-body MRI system, superconducting magnet
No Description
CAYENNE MEDICAL, INC.
CM-6265
In Commercial Distribution



  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
CAYENNE MEDICAL, INC.
CM-6255
In Commercial Distribution



  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
  • Tendon/ligament bone anchor, non-bioabsorbable
No Description
MAZOR ROBOTICS LTD
TPL0059-08
In Commercial Distribution

  • 07290109184838 ()


  • Multi-purpose stereotactic surgery system
No Description
MAZOR ROBOTICS LTD
TPL0059-07
In Commercial Distribution

  • 07290109184098 ()


  • Multi-purpose stereotactic surgery system
No Description
MAZOR ROBOTICS LTD
TPL0059-10
In Commercial Distribution

  • 07290115751895 ()


  • Multi-purpose stereotactic surgery system
No Description
MAZOR ROBOTICS LTD
TPL0059-09
In Commercial Distribution

  • 07290115751376 ()


  • Multi-purpose stereotactic surgery system
PLASMABLADE X PS200-041S 4.0S PINK
MEDTRONIC NAVIGATION, INC.
PS200-041S
In Commercial Distribution

  • 00763000059880 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS200-041S 4.0S
MEDTRONIC NAVIGATION, INC.
PS200-041S
In Commercial Distribution

  • 00763000059873 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS200-041-PINK 4.0 PINK
MEDTRONIC, INC.
PS200-041-PINK
In Commercial Distribution

  • 00763000059859 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS200-040 4.0 GREEN
MEDTRONIC NAVIGATION, INC.
PS200-040
In Commercial Distribution

  • 00763000059842 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS210-031S-PINK 3.0S PINK
MEDTRONIC, INC.
PS210-031S-PINK
In Commercial Distribution

  • 00763000059828 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
15 in x 26 in (38.1 cm x 66 cm), Clear
CROSSTEX INTERNATIONAL, INC.
BCXR
In Commercial Distribution

  • 50732224003325 ()
  • 10732224003327 ()
  • 00732224003320 ()


  • Medical equipment/instrument drape, single-use
PLASMABLADE X PS210-030S 3.0S GREEN
MEDTRONIC NAVIGATION, INC.
PS210-030S
In Commercial Distribution

  • 00763000059811 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
PLASMABLADE X PS210-030S PINK
MEDTRONIC NAVIGATION, INC.
PS210-030S
In Commercial Distribution

  • 00643169936683 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, single-use
No Description
MAZOR ROBOTICS LTD
TPL0059-06
Not in Commercial Distribution

  • 07290109183213 ()


  • Multi-purpose stereotactic surgery system
No Description
MAZOR ROBOTICS LTD
TPL0059-05
Not in Commercial Distribution

  • 07290109181158 ()


  • Multi-purpose stereotactic surgery system
Mazor X System
MAZOR ROBOTICS LTD
TPL0059-04
Not in Commercial Distribution

  • 07290109180465 ()
TPL0059-04

  • Multi-purpose stereotactic surgery system
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